Lupin says FDA raises concerns over Pithampur plant

The FDA inspected the plant in January this year, after which it issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant, Lupin said in a statement, without giving details.

February 23, 2015 / 22:17 IST

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Indian drugmaker Lupin Ltd said on Monday that the US Food and Drug Administration (FDA) has raised concerns over production processes at the company's Pithampur plant in central India.

The FDA inspected the plant in January this year, after which it issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant, Lupin said in a statement, without giving details.

Lupin said it has received one drug approval and two site-transfer approvals from the same plant since the FDA audit.

In a Form 483, the FDA typically outlines conditions or practices at a drug-making unit that may cause the products made there to be in violation of the US agency's standard production requirements.

first published: Feb 23, 2015 03:17 pm

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